Automation Validation Lead

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Principal Objective: The Automation Validation Lead is responsible for overseeing all automation testing (leveraged software Factory Acceptance Tests, Commissioning and Validation) to ensure successful validation of all automation systems in the ACMF/Building E at the Site.

Reporting: The Automation Validation Lead will report to the Automation Lead and additionally take direction from the Project’s Validation Lead. The Automation Validation Lead will be an active member of the overall project team working with the team, Engineer of Record and Construction Manager.

Key Responsibilities: • Finalize the Automation Validation Plan • Work with a team of engineers and System Integration (SI) contractors to complete all validation deliverables related to the Delta-V Manufacturing Control System (MCS) and Qualified Utilities Network (QUN) • Give guidance on validation best practices for automation hardware, software and computer systems. • Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance • Draft, review or approve automation design and testing documents for all phases of testing (sFAT, Commissioning, Validation) • Drive deviation resolution for all testing

Requirements

• • 7 years of relevant automation validation experience • The candidate must have a strong background working in cGMP environments. • The candidate must have excellent communication skills. • Experience with Emerson Controllers and Emerson DeltaV Software is required.

• The ideal candidate would have experience with the following hardware: · Allen Bradley PLCs and I/O

• The ideal candidate would have experience with the following software: · GE’s Proficy FIX · OSISoft’s OSIPi or similar Historian software · Reporting software, InfoBatch is preferred

• The ideal candidate should be familiar with the following communication methods/protocols: · Ethernet · Profibus · OPC

• The ideal candidate should be familiar with the following computer system software and hardware: · Windows operating systems · Windows Terminal Services/Remote Desktop · VMWare · Dell VRTX familiarity is a plus

• Countries / Regions of Expected Travel: Limited local travel to software Factory Acceptance Tests (FATs) may be required

Requirements

• • 7 years of relevant automation validation experience • The candidate must have a strong background working in cGMP environments. • The candidate must have excellent communication skills. • Experience with Emerson Controllers and Emerson DeltaV Software is required.

• The ideal candidate would have experience with the following hardware: · Allen Bradley PLCs and I/O

• The ideal candidate would have experience with the following software: · GE’s Proficy FIX · OSISoft’s OSIPi or similar Historian software · Reporting software, InfoBatch is preferred

• The ideal candidate should be familiar with the following communication methods/protocols: · Ethernet · Profibus · OPC

• The ideal candidate should be familiar with the following computer system software and hardware: · Windows operating systems · Windows Terminal Services/Remote Desktop · VMWare · Dell VRTX familiarity is a plus

• Countries / Regions of Expected Travel: Limited local travel to software Factory Acceptance Tests (FATs) may be required

• All your information will be kept confidential according to EEO guidelines.